跳至主要内容
临床试验/NCT06344221
NCT06344221Unknown不适用

Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study

Centre Hospitalier St Anne0 个研究点目标入组 90 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence

研究概览

简要总结

The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect.

详细描述

Firstly, the investigators would like to carry out a study into the validity of measuring haptic deficits using vibro-tactile sensors positioned on the hands of chronic stroke patients and young and elderly healthy subjects. They believe that identifying the haptic deficit using a simple and rapid method, in combination with motor training, could make it possible to improve the prediction of recovery and personalise the rehabilitation of manual dexterity deficits after stroke. They will also compare the effect of tactile feedback with that of auditory feedback in order to study the specificity of the effect of this feedback on manual dexterity. In the second part, to better understand this and to study the cortical mechanisms involved in sensory-motor integration, the investigators propose to measure the haptic effect on cortical excitability in stroke patients and healthy subjects using Transcranial Magnetic Stimulation (TMS).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for healthy controls:
  • •between 18 and 40 years old
  • •or age and sex match with chronic stroke patients
  • •Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment
  • •Inclusion Criteria for chronic stroke patients:
  • •More than 18 years old
  • •Ability to perform motor, cognitive (MOCA score ≥26/30) and sensory assessment
  • •First symptomatic stroke more than 6 months ago
  • •Upper limb paresis (≤4/5 on the MRC scale)
  • •Feel ≥3/6 touch on the index and thumb fingers
  • •Box and Blocks test score between 1 and 54 blocks / min

排除标准

  • •Contraindication to TMS (epilepsy, metal implants)

研究组 & 干预措施

Young Healthy Controls

Active Comparator

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

干预措施: Dextrain Manipulandum and haptic feedback device (Device)

Healthy controls matched in age and sex with stroke patients

Active Comparator

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

干预措施: Dextrain Manipulandum and haptic feedback device (Device)

Chronic stroke patients

Experimental

The 3 groups, made up of participants with different pathologies and ages, will receive the same intervention (clinical motor and sensory tests and optional TMS). We are studying the difference in results between these groups.

干预措施: Dextrain Manipulandum and haptic feedback device (Device)

结局指标

主要结局

Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence

时间窗: 1 day

Comparison of finger independence, assessed with the Dextrain Manipulandum tool with and without sensory feedback (vibrations on the fingers). Measurement of the difference in motor performance between the condition with and without vibrations.

次要结局

  • Correlation between clinical assessment and haptic measure(1 day)
  • Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks)(1 day)
  • Assessment of the feasibility of the haptic measures(1 day)
  • Assessment of the benefits of the haptic measures(1 day)
  • Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator(1 day)
  • Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity)(1 day)
  • Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index(1 day)
  • Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity(1 day)
  • Transcranial magnetic stimulation (TMS)(1 day)

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

相似试验